FDA Reform: Disproving Intelligent Design Theory

  • by: |
  • 11/17/2006
To read the testimony of all of but one (and a half) of the witnesses who presented before the Senate HELP committee, you can't help wonder whether the object was to pay homage to the dreadful IOM report or ignore the connection between science and FDA reform. Witnesses -- with the exception of Greg Simon's Faster Cures and the head of Benefit and Risk analysis at J and J were literally tripping over themselves talking about how important it was to spend all this money on making sure each and every drug was equally safe. Only Greg and the J and J guy managed to point out that embedding bean counters and epidemiologists from the Office of Drug Safety and giving them authority over drug appovals and study designs might add to the cost and time of new drug approvals without regard to the relative benefits of medicines. And the entire discussion was disconnected from ongoing efforts by the FDA to make pre-approval a more targered path that actually focused on eliminating safety problems.

Only Greg pointed out that the real value of a cliniical ttrials registry was to help avoid potential safety flaws and develop more targeted medicines and treatment regimens on a real time basis. (I think the industry is inching towards acceptance ... as it should)

And only Greg made the point, diplomatically, that the real crisis is not a lack of safe drugs but a lack of effective CURES being developed for patients being killed and crippled by horrible illnesses. As Garret Fitzgerald cogently observed and was cogently quoted (kudos to those reporters who did their job in this regard) with respect to studies about Arcoxia, Merck's latest COX-2, the use of many drugs for broadly shared problems (pain) will have to be tailored by metabolic response, age, co-morbidity, instead of banned and panned outright.

There is an unhealthy relationship between the HELP committee and the IOM panel ... There is no speaking truth to power. Instead, it is an effort on the part of the IOM committee to pass legislation it likes. I hope the committee ignores IOM and listens to Greg Simon.

Better use of medicines in a targeted fashion require a total feedback loop and not a balance of cultures or a massive purcahse of claims databases or the FDA's equivalents of a quasi-kosher certification as the IOM proposes. It would have been nice if the IOM had some really scientists on the panel...but that would have meant having a chair who wasn't threatend byy such expertise....

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog